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Occlusal Wear Of Bioflx Crowns Compared To Zirconia Crowns On Primary Molars

ConditionCarious Primary Molars
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-8
SponsorCairo University

About this trial

The goal of this clinical trial is to evaluate the occlusal wear of Bioflx crowns compared to zirconia crowns in the restoration of primary molars.

The main question\[s\] it aims to answer : " Is there a difference in the occlusal wear of BioFlx crowns compared to zirconia crowns in the restoration of primary molars?" The study will also assess the clinical performance of both types of crowns in terms of retention,gingival health, preparation time, as well as child and parental satisfaction.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children aged between 4 and 8 years with primary molar that needs to be covered by crown.

Medically healthy children (ASA I or II according to the American Society of Anesthesiologists classification).

Children whose parent or guardian are willing to sign an informed consent.

Children whose parent or guardian are willing to comply with follow-up visits. -

Disqualifiers

Molars with severe structural loss that may compromise crown retention.

Children with poor oral hygiene that may contribute to higher plaque levels and affect the clinical outcomes of the crown restorations.

Children with history of allergies; Known allergies to dental local anesthesia or to the materials used in Bioflx crowns.

Children with any systemic conditions or disabilities that may affect their ability to participate in the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • (Group A: Preformed Bioflx Crown)

    Other intervention

    Crown Selection \& Tooth Preparation Measure the mesiodistal width using calipers to select an appropriately sized crown. If a mesial or distal wall is missing, use the contralateral tooth for size selection. Choose the crown that closely matches the measured mesiodistal width. Select the smallest crown that preserves proximal contacts using a trial-and-error approach. if crimping is necessary use Howe's pliers. Tooth Preparation Perform 1-1.5 mm occlusal reduction using a tapered diamond bur. Reduce proximal areas by approximately 0.5 mm to clear the contact area. Crown Placement \& Cementation Ensure a snug fit of the selected crown. Apply a thin layer of glass ionomer cement inside the crown. Seat the crown firmly using finger pressure. Have the child bite down gently to ensure proper seating. Final Adjustments \& Cleanup Remove excess cement with floss or an explorer. Verify the crown's fit, occlusion, and stability.

  • (Group B: Preformed Zirconia crown)

    Other intervention

    Crown Selection Measure the mesiodistal width using calipers to select the appropriate crown. If a mesial or distal wall is missing, use the contralateral tooth for size selection. Choose the crown that closely matches the measured width. Select the smallest crown that preserves proximal contacts. Tooth Preparation Reduce the occlusal surface by 1.5-2 mm using a tapered diamond bur. Reduce interproximal areas by 1-1.5 mm, ensuring a feather-edge finish. Perform a 1-2 mm subgingival preparation using a tapered fissure bur. Crown Placement \& Passive Fit Check Place the selected crown and check for passive fit. Cementation of the Crown Apply a thin layer of glass ionomer cement inside the crown. Seat the crown with passive finger pressure. Have the child bite down gently to ensure proper seating. Final Adjustments \& Cleanup Remove excess cement using floss or an explorer. Verify fit, occlusion, and stability

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: (Group A : preformed Bioflx crownExperimental treatment 1 intervention
Group B: (Group B: Preformed zirconia crown)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Occlusal wear of crown

Measure by Modified United States Public Health System criteria: Alpha: Occlusal surface intact. Bravo: Wear of occlusal surface without tooth surface exposure Charlie: Wear of occlusal surface with exposure

Time frame
T (Time): 12months interval T0: 0 T1: 3 month T2: 6month T3: 12 month]

Secondary outcomes

1

Retention

Measure by :Modified United States Public Health System criteria:Alpha: Intact Bravo:Chipped/loss of material Charlie: Complete loss of crown

Time frame
[Time Frame: follow-up:T (Time): 12months interval T0: 0 T1: 3month T2: 6month T3 : 12 month]
2

Gingival Health

Measure by: Gingival index: 0: healthy gum 1. mild discoloration and edematous gingiva no bleeding on probing 2. red oedematous and shiny gingiva bleeding on probing 3. red oedematous and ulceration gingiva spontaneous bleeding

Time frame
T (Time): 12 months interval T0: 0 T1: 3month T2: 6month T3 : 12 month]
3

preparation time

Measure by : Stopwatch per minutes.

Time frame
[Time Frame: baseline]
4

child and parental satisfaction

Measure by: 5-Point likert's scale units of measurement 1. very happy 2. happy 3. neither 4. unhappy 5. very unhappy / Questionnaire:Ordinary or N/ A existing validated tool

Time frame
[Time Frame: T (Time): 12months interval T0: 0 T1: 3 month T2: 6month T3: 12 month]

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Faculty of dentistry cairo university Status unavailable 12613, Cairo ,Giza, EgyptEgyptEgypt

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

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